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Increased major bleeding incidence in atrial fibrillation patients with apixaban: a review of Japanese post-marketing surveillance studies of direct oral anticoagulants
AbstractLarge-scaled post-marketing surveillance studies (PMSSs) of 4 direct oral anticoagulants (DOACs) for stroke prevention in non-valvular atrial fibrillation (AF) were conducted since 2011 in Japan, and the results of the last one have recently been published. Each reported a more than acceptable ischemic stroke prevention. The major bleeding rates were also acceptably low and comparable to each other in the PMSSs of dabigatran (J-dabigatran), rivaroxaban (XAPASS), and edoxaban (ETNA-AF-Japan). However, the incidence in PMSS of apixaban (STANDARD) was more than double the others. This finding appeared to contradict th...
Source: European Journal of Clinical Pharmacology - April 25, 2023 Category: Drugs & Pharmacology Source Type: research

An emulated target trial analysis based on Medicare data suggested non-inferiority of Dabigatran versus Rivaroxaban
Atrial fibrillation (AF) is an abnormal heart rhythm characterized by rapid and irregular heart chamber beatings. It affects three to six million people in the U.S.1, among whom 85% to 90% are eligible for oral anticoagulation therapies2,3. As established in the literature, it is of great interest to properly choose among non-vitamin K antagonist oral anticoagulants (NOACs). Rivaroxaban and Dabigatran were approved by the U.S. FDA in November 2011 and October 2010, respectively. They were the first two NOACs for preventing stroke for non-valvular AF patients and have been widely used since marketing.
Source: Journal of Clinical Epidemiology - July 13, 2021 Category: Epidemiology Authors: Hao Mei, Jiping Wang, Shuangge Ma Source Type: research

Extension of Disease Risk Score-Based Confounding Adjustments for Multiple Outcomes Of Interest- An Empirical Evaluation.
Abstract Use of disease risk score (DRS)-based confounding adjustment when estimating treatment effects on multiple outcomes is not well studied. Using an empirical example comparing dabigatran versus warfarin on ischemic stroke and major bleeding risk in 12 sequential monitoring periods (90 days each) using the Truven Marketscan database, we compared two approaches for combining DRS for multiple outcomes: (1) 1:1 matching on prognostic propensity scores (PPS), created using DRS for bleeding and stroke as independent variables in a propensity score (PS) model; and (2) simultaneous 1:1 matching on DRS for bleeding ...
Source: Am J Epidemiol - June 26, 2018 Category: Epidemiology Authors: Desai RJ, Wyss R, Jin Y, Bohn J, Toh S, Cosgrove A, Kennedy A, Kim J, Kim C, Ouellet-Hellstrom R, Karami S, Major JM, Niman A, Wang SV, Gagne JJ Tags: Am J Epidemiol Source Type: research

The case for dosing dabigatran: how tailoring dose to patient renal function, weight and age could improve the benefit-risk ratio
Dabigatran is increasingly being used in clinical practice for the thromboprophylaxis in atrial fibrillation as a convenient therapy that needs no drug level monitoring. However, analysis of the data of the same clinical trial that led to the adoption of dabigatran in fixed-dosing regimens has indicated a small subgroup of patients that could be either over-treated, risking bleeding, or under-treated, risking embolism. Additional post-marketing data lends support to the favorable therapeutic profile of dabigatran but at the same time raises doubts about patient characteristics such as weight, age, renal function and their ...
Source: Therapeutic Advances in Neurological Disorders - October 27, 2015 Category: Neurology Authors: Safouris, A., Triantafyllou, N., Parissis, J., Tsivgoulis, G. Tags: Reviews Source Type: research

Hemorrhagic stroke and new oral anticoagulants.
Abstract The recent release of new oral anticoagulants (NOAC) raises the question of the management of intracranial hemorrhage occurring during treatment with these molecules. Dabigatran, rivaroxaban and apixaban have different pharmacological characteristics that physicians need to know to adjust their prescription to each patient. Studies of efficacy and safety prior to the marketing of these molecules showed a decreased risk of intracranial hemorrhage compared with vitamin K antagonists. However, no reliable data are available regarding the prognosis of these hemorrhages occurring during NOAC treatment. In addi...
Source: Annales Francaises d'Anesthesie et de Reanimation - October 1, 2014 Category: Anesthesiology Authors: Derlon V, Corbonnois G, Martin M, Toussaint-Hacquard M, Audibert G Tags: Ann Fr Anesth Reanim Source Type: research

Reply Regarding the Effect of Dabigatran Plasma Concentrations
We would like to respond to Dr. Rao's questions concerning our paper (1). First, it is incorrect to state that any data on dabigatran and plasma levels were suppressed. This information has been submitted to all regulatory authorities as part of the original registration process of dabigatran etexilate for reduction of stroke in patients with atrial fibrillation. These data have also been in the public domain since the U.S. Food and Drug Administration (FDA) Advisory Committee meeting in September 2010, before marketing approval (2).
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - June 23, 2014 Category: Cardiology Source Type: research

Reservations against new oral anticoagulants after stroke and cerebral bleeding
Abstract: Dabigatran, rivaroxaban, and apixaban are the new oral anticoagulants (NOAC) which have been investigated in patients with atrial fibrillation (AF) for primary and secondary prevention of stroke and thromboembolism. In these trials NOAC had a similar efficacy and safety profile compared to traditional vitamin-K-antagonists such as warfarin. We advise caution in the use of NOAC in patients with stroke or cerebral hemorrhage because of the following reasons:1) Patients with cerebral bleeding were excluded from the trials. 2) Stroke within 14days and severe stroke within 6months before screening were exclusion crite...
Source: Journal of the Neurological Sciences - April 29, 2013 Category: Neurology Authors: Claudia Stöllberger, Josef Finsterer Tags: Opinion Source Type: research

NICE issues final guidance supporting the use of apixaban for prevention of stroke and systemic embolism in non-valvular atrial fibrillation (TA 275)
Source: NICE Area: Evidence > Guidelines NICE has issued final guidance (TA 275) supporting the use of apixaban as an option for preventing stroke and systemic embolism within its marketing authorisation, that is, in people with nonvalvular atrial fibrillation with 1 or more risk factors such as:   . prior stroke or transient ischaemic attack . age 75 years or older . hypertension . diabetes mellitus . symptomatic heart failure.   NICE notes that the decision about whether to start treatment with apixaban should be made after an informed discussion between the clinici...
Source: NeLM - Cardiovascular Medicine - February 27, 2013 Category: Cardiology Source Type: news